Sparflo - Instructions For The Use Of Tablets, Price, Analogs, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sparflo

Sparflo: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Sparflo

ATX code: J01MA09

Active ingredient: sparfloxacin (sparfloxacin)

Manufacturer: Dr. Reddy's Laboratories Ltd. (India)

Description and photo update: 2019-04-10

Sparflo is a drug from the group of fluoroquinolones with antibacterial action.

Release form and composition

Sparflo is produced in the form of coated tablets: oval, light yellow or almost white, on one side with a line, on the other - embossed “200” (6 pieces in blisters, one blister in a cardboard box).

Composition for 1 tablet:

• active substance: sparfloxacin - 200 mg;
• auxiliary components: magnesium stearate, crospovidone, corn starch, colloidal silicon dioxide, microcrystalline cellulose, talc;
• tablet shell: propylene glycol, talc, hypromellose, titanium dioxide, quinoline yellow dye.

Pharmacological properties

Pharmacodynamics

Sparfloxacin is a fluoroquinolone derivative, antimicrobial drug, inhibitor of bacterial DNA gyrase, which despiralizes sections of chromosomal DNA.

Sparflo is characterized by low toxicity in relation to the cells of the macroorganism, which is explained by the absence of gyrases in their structure. Provides bactericidal and antimicrobial effects against gram-negative and gram-positive flora. Has an increased activity against gram-positive cocci and anaerobes in comparison with previous generations of fluoroquinolones. In relation to gram-negative flora, it exhibits an activity similar to that of aminoglycosides.

The bactericidal effect on gram-positive microorganisms is provided only during the period of division, on gram-negative organisms - during the periods of division and rest (affects DNA gyrase and promotes lysis of the cell wall).

Sparflo interferes with the transcription of the genetic material of bacteria, which prevents their normal metabolism and reduces the ability to divide. As a result of this effect, there is no parallel development of resistance to other antibiotics not from the group of gyrase inhibitors, and the high efficiency of the drug against bacteria resistant to penicillins, aminoglycosides, tetracyclines, cephalosporins and other antibiotics is ensured.

The following pathogenic microorganisms are susceptible to sparfloxacin: Shigella spp., Escherichia coli, Citrobacter spp., Salmonella spp., Enterobacter spp., Klebsiella spp., Hafnia spp., Serratia spp., Proteus spp. (indole-negative and indole-positive), Providencia spp., Edwardsiella spp., Yersinia spp., Morganella spp., Aeromonas spp., Vibrio spp., Pasteurella spp., Plesiomonas spp., Campylobacter spp., Haemophilus spp., Pseudomonas aeruginosa, Pseudomonas cepacia, Neisseria spp., Legionella spp., Acinetobacter spp., Moraxella spp., Staphylococcus spp., Brucella spp., Mycoplasma pneumonia, Streptococcus pneumoniae, Corynebacterium spp., Lomonasth.

Sparfloxacin is highly active against various strains of Mycobacterium tuberculosis, including multi-resistant strains.

Ureaplasma urealyticum, Enterococcus faecium, Nocardia asteroids are usually sensitive to sparfloxacin. The following microorganisms are of moderate sensitivity: Flavobacterium spp., Gardnerella spp., Streptococcus agalactiae, Alcaligenes spp., Streptococcus pyogenes, Enterococcus faecalis, Mycoplasma hominis, Streptococcus viridans, Mycobacterium fortuitum.

Anaerobic microorganisms, with a few exceptions, are moderately susceptible (Peptostreptococcus spp., Peptococcus spp.) Or resistance (Bacteroides spp.). Sparfloxacin is ineffective against Treponema pallidum.

The development of resistance to sparfloxacin is extremely slow, since after its use, persistent microorganisms almost completely disappear, and bacterial cells do not have enzymes inactivating it.

No cross-resistance to other antimicrobial agents has been reported.

It is inferior to ciprofloxacin in activity against gram-negative bacilli, in particular, Pseudomonas aeruginosa.

Has a postantibiotic effect: within 0.5-4 hours after the disappearance of sparfloxacin from the plasma, microorganisms do not multiply.

Pharmacokinetics

After oral administration, absorption is about 90%. Taking Sparflo with milk or food does not affect the degree of absorption. In the latter case, the rate of absorption slows down, but without changing the degree of absorption, and the maximum concentration of sparfloxacin is observed approximately 30 minutes later than when taken on an empty stomach.

The drug is well distributed throughout the tissues of the body (with the exception of tissue rich in fats, including the nervous one). The concentration in plasma is lower than in fluids and tissues of the lower respiratory tract. It is found in high concentrations in alveolar macrophages. In saliva, bile, abdominal organs, small pelvis, intestines, kidneys, urinary organs, bronchial secretions, lung tissue, muscles, bone tissue, synovial fluid, articular cartilage, peritoneal fluid, skin, therapeutic concentrations are achieved. In the intraocular and cerebrospinal fluids, 10% of the drug content in plasma is found.

The volume of distribution is 3.9 + 0.8 l / kg and exceeds those for other fluoroquinolones. About 45% binds to blood plasma proteins (mainly albumin).

After oral administration of Sparflo at a dose of 400 mg, the maximum concentration is reached after 3–6 hours. In tissues, the concentration is 2–12 times higher than that for plasma. The dependence of the concentration of the drug in the blood serum from the dose taken is linear.

At acidic pH values, the activity decreases slightly.

It is metabolized in the liver, from 30 to 50% is excreted in the feces, the rest in the urine (due to tubular filtration and tubular secretion). About 10% of the dose taken is excreted unchanged. The half-life is 16 to 30 hours. With renal failure, the half-life is increased.

In patients with chronic renal failure, the proportion of the drug excreted through the kidneys decreases. With a creatinine clearance of more than 20 ml / min, cumulation in the body is not observed, since metabolism and excretion with feces increase in parallel.

Indications for use

According to the instructions, Sparflo is used for infectious and inflammatory diseases caused by microorganisms sensitive to sparfloxacin:

• infections of the paranasal sinuses and middle ear (especially infections caused by gram-negative bacteria, including Staphylococcus spp. and Pseudomonas spp.);
• respiratory infections (including exacerbations of chronic obstructive pulmonary diseases and pneumonia caused by Haemophilus influenzae, Streptococcus pneumonia, Klebsiella pneumoniae, Mycoplasma pneumonia, Staphylococcus spp., Moraxella catarrhalis, Enterobacter cloacae, Chlamydia pneumoniae, Haemlufine)
• pulmonary tuberculosis (in case of intolerance to first-line treatment or drug-resistant tuberculosis);
• eye infections;
• bacterial infections of the gastrointestinal tract (including salmonellosis and shigellosis);
• abdominal infections (including biliary tract infections);
• leprosy;
• joint and bone infections (including osteomyelitis);
• infections of soft tissues and skin (including furunculosis, abscesses, infectious dermatitis and pyoderma);
• genital infections (including prostatitis and adnexitis);
• sexually transmitted infections (including chlamydia, gonorrhea);
• infections of the urinary tract and kidneys (including pyelitis, cystitis, and non-gonococcal urethritis);
• infections in patients with immunodeficiency (including in patients with neutropenia or during therapy with immunosuppressants).

Contraindications

Absolute:

• severe renal failure;
• lengthening of the QT interval and other conditions that contribute to the occurrence of arrhythmias (severe bradycardia, atrial fibrillation, hypokalemia, congestive heart failure);
• epilepsy;
• deficiency of the enzyme glucose-6-phosphate dehydrogenase;
• children and adolescents up to 18 years of age (due to the incompleteness of the skeleton formation process);
• During pregnancy and breastfeeding;
• hypersensitivity to the main or auxiliary components of the drug.

Relative (Sparflo is used with caution):

• chronic renal failure;
• disorders of cerebral circulation;
• cerebral atherosclerosis;
• convulsive syndrome;
• conditions of professional activity or life that do not allow limiting insolation.

Instructions for use of Sparflo: method and dosage

Sparflo tablets are intended for oral administration, regardless of the meal. The tablet should be swallowed whole without chewing and drinking plenty of water or other liquid.

The duration of therapy depends on the clinical course and severity of the disease, as well as the results of bacteriological analysis.

Recommended doses of Sparflo:

• ENT infections (including sinusitis): 400 mg of sparfloxacin once on the first day of treatment, then 200 mg per day for 10 days;
• exacerbation of chronic bronchitis, pneumonia: 400 mg of the drug once on the first day of treatment, then 200 mg per day for 10 days; in patients with impaired renal function (creatinine clearance less than 50 ml / min) on the first day of treatment, a standard initial dose is used, then 200 mg of sparfloxacin every 48 hours;
• pulmonary tuberculosis (in combination with anti-tuberculosis drugs): 400 mg Sparflo once on the first day of treatment, then 200 mg per day for 30 days;
• leprosy: 200 mg per day once for 12 weeks;
• infections of soft tissues and skin: 400 mg once on the first day of treatment, then 200 mg per day for 3–9 days;
• bacterial prostatitis and chlamydial infections: 400 mg of sparfloxacin once on the first day of treatment, then 200 mg per day for 10-14 days;
• acute gonorrheal urethritis: 400 mg once on the first day of treatment, then 200 mg every 24 hours (600 mg per course);
• non-gonococcal urethritis: 200 mg of the drug once on the first day of treatment, then 100 mg per day for 6 days;
• urinary tract infections: 200 mg once on the first day of treatment, then 100 mg per day for 10-14 days.

Side effects

• digestive system: dyspepsia, poor appetite, vomiting, nausea, flatulence, abdominal pain, hepatitis, cholestatic jaundice, hepatonecrosis, hyperbilirubinemia, increased activity of alkaline phosphatase and hepatic transaminases;
• cardiovascular system: tachycardia, flushing of the face, prolongation of the QT interval, cerebral artery thrombosis;
• hematopoietic system: leukopenia, thrombocytopenia, thrombocytosis, eosinophilia, anemia, hemolytic anemia, granulocytopenia, leukocytosis;
• central and peripheral nervous system: drowsiness, nightmares, headache, anxiety, confusion, hallucinations, fainting, dizziness, increased fatigue, tremor, increased intracranial pressure, depression, psychotic reactions, migraine, pain perception abnormality;
• sense organs: hearing loss and tinnitus, visual impairment (change in color perception, diplopia), impaired sense of smell and taste;
• musculoskeletal system: arthritis, arthralgia, tendovaginitis, myalgia;
• urinary system: crystalluria (with low diuresis and alkaline urine reaction), the presence of blood in the urine, hypercreatininemia;
• allergic and dermatological reactions: erythema nodosum, pruritus, photosensitivity, toxic epidermal necrolysis, drug fever, exudative erythema multiforme, laryngeal and facial edema;
• other reactions: general weakness, small capillary hemorrhages, shortness of breath, deficiency of the coagulation factor prothrombin in the blood, increased sweating, hyperglycemia.

Overdose

The specific antidote is unknown. Treatment: symptomatic therapy, if necessary, peritoneal dialysis and hemodialysis.

special instructions

During the period of treatment with Sparflo, as well as for three days after the end of therapy, patients should avoid ultraviolet radiation.

In isolated cases, the use of fluoroquinolones led to tendon rupture. If complaints occur, the drug should be canceled.

Do not exceed the prescribed daily dose. During treatment, the patient must consume a sufficient amount of fluid, it is also necessary to ensure that the acidic reaction of the urine is maintained in order to prevent the development of crystalluria.

During the period of treatment with Sparflo, it is advisable to refrain from any potentially dangerous activity that requires a quick reaction and increased attention.

Application during pregnancy and lactation

It is forbidden to use Sparflo during pregnancy and lactation.

Pediatric use

It is forbidden to use Sparflo to treat patients under the age of 18.

With impaired renal function

It is forbidden to use Sparflo in severe renal failure. The drug must be used with caution in chronic renal failure.

Drug interactions

With simultaneous use with non-steroidal anti-inflammatory drugs (with the exception of acetylsalicylic acid), the risk of seizures increases.

It is not recommended to use Sparflo at the same time as drugs that prolong the QT interval (tricyclic antidepressants, erythromycin, phenothiazine, bepridil, pentamidine, class IA and III antiarrhythmic drugs, terfenadine, astemizole, cisapride).

When sparfloxacin is combined with other antimicrobial agents (metronidazole, aminoglycosides, beta-lactam antibiotics, clindamycin), synergism is usually observed.

With simultaneous use with cyclosporine, serum creatinine increases (this indicator needs to be monitored twice a week).

Sparfloxacin has almost no effect on the concentration of indirect anticoagulants, oral hypoglycemic agents and theophylline.

When using Sparflo with antacids, sucralfate and iron-containing agents, the absorption of sparfloxacin decreases, so Sparflo should be taken 1-2 hours before or 4 hours after taking the listed funds.

Metoclopramide accelerates the absorption of the drug and reduces the time to reach its maximum concentration.

Analogs

Sparflo analogues are Sparfloxacin, Respara, Sparbakt.

Terms and conditions of storage

Store in a dark, dry place at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sparflo

Reviews of Sparflo are mostly positive: users note the effectiveness, speed and simplicity of the treatment regimen. The main disadvantages are toxicity and a long list of side effects.

Price for Sparflo in pharmacies

The approximate price for Sparflo is 340 rubles. for 6 tablets 200 mg.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!